The FDA inspection at Innokas Medical Helsinki factory completed with an excellent result

Recent news, articles & releases

The FDA conducted an inspection at Innokas Medical’s Helsinki factory at the end of October during which it evaluated how Innokas follows FDA Quality Systems requirements (21 CFR part 820). Both the inspector and Innokas Medical are satisfied with the results of the inspection as there were no observations given to Innokas.

US FDA, i.e. the Food and Drug Administration, is the authority responsible for monitoring e.g. food, medication, and medical devices in the USA. The purpose of its operation is to ensure the safety of the people using these products. In general, the authority for example regulates and inspects medical device manufacturers to ensure that the medical devices exported to US are safe and effective.

The FDA inspections are thorough and objective. In principle, if everything is not up to par as a whole, an inspector could immediately deny permission to market a product in the USA on the basis of the observations found in an inspection. In Finland this is rare, but for example in Asia this may happen sometimes, and in USA, FDA may even close whole factories. But usually, some observations are made, and companies have to respond with a corrective action plan and then implement that corrective action plan expeditiously. The FDA also monitors implementation of the plan for fixing the flaws.

The agency’s representative arrived to inspect the quality of the manufacturing process of Elekta’s MEG device at Innokas Helsinki factory in the end of October. Because the device is manufactured by Innokas, the FDA inspected both the product marketer and Innokas’ manufacturing process.

“The FDA conducts general inspections of European companies approximately every four to six years. This kind of inspection, related to individual product, may be conducted at any time at Innokas as we partner with medical device OEMs offering contract manufacturing of their medical devices”, Innokas Medical's QA/RA Director Tiina Kotipalo explains.

The inspection conducted at Innokas Medical was completed with an excellent result. In the inspection all the processes and actions related to the manufacturing of Elekta’s MEG devices were inspected in a very detailed level, and the inspector didn’t make any observations. Kotipalo is very happy about the results as it is not that rare that the authority makes some, even minor observations, when inspecting company’s processes.

“The FDA inspection was thorough and objective, and it ended with an excellent result. The inspector did not make any observations. This is excellent, and thanks belongs to all Innokas employees! Innokas has done systematic work for years, becoming familiar with the FDA’s requirements and making sure the company’s operations meet them - which can be seen through the inspection results now. It is a point of honor to us to take care that the manufacturing processes at Innokas follow all the required directives and regulations”, Kotipalo says.

Picture of Elina Ihme
Written by Elina Ihme
Head of Marketing and Communications
Quality & Regulatory Affairs, News, FDA, Medical Device Manufacturing